Ignite Creation Date:
2024-05-06 @ 8:21 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02721069
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2016-03-17
Brief Title:
Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects
Sponsor:
Neurelis Inc
Organization:
Neurelis Inc
Study Overview
Official Title:
A 12-Month Open-Label Repeat-Dose Safety Study of NRL-1 in Epilepsy Subjects DIAZ00105
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 12 month safety study to evaluate the safety of repeated doses of NRL-1
Detailed Description:
This is a Phase 3 repeat dose open-label safety study in Epilepsy subjects who have frequent breakthrough seizures or Acute Repetitive Seizures ARS NRL-1 will be administered as needed to treat bouts of those seizures over a 12-month period of time Doses will be defined as 5 mg 10 mg 15 mg or 20 mg based on the subjects body weight A diary will be used to record the seizure and NRL-1 administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None